Quality Engineer

Gi Group Holding; Athlone; On-site; EUR 50,000 - 55,000; Full time

Job summary

A Quality Engineer position in Athlone, Ireland, is available to support the maintenance and continual improvement of the Quality Management System in line with FDA and ISO 13485 standards.

You will lead CAPA and NCR activities, assist with audits, and collaborate across Manufacturing and Engineering to drive process improvements and risk management. A degree in a relevant field and 3–4 years of quality engineering experience are required.

Qualifications

• Bachelor's or Master's degree in Science, Manufacturing Engineering, Biomedical Engineering, Quality or a related discipline.
• 3-4 years' experience within Quality Engineering, Quality Assurance or a similar role in a regulated manufacturing environment.
• Experience with FDA Quality System requirements and ISO 13485 awareness.
• Experience with CAPA, NCRs, root cause analysis, change control, risk management and audits.

Responsibilities

• Support the maintenance and continuous improvement of the QMS in compliance with FDA requirements, ISO 13485 and applicable standards.
• Lead and support quality activities including root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate NCRs and ensure effective root cause analysis and timely closure.
• Support CAPA development, implementation and effectiveness monitoring.
• Support internal and external audits, including preparation, audit responses and follow-up actions.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues and drive continuous process improvement.
• Support product and process risk assessments, process validation and equipment qualification.
• Review and maintain QMS documentation including procedures and work instructions.
• Support supplier quality activities including supplier issues and corrective actions.
• Support change control activities for product and process changes.
• Analyze quality data and trends to identify improvement opportunities.
• Promote a strong quality and continuous improvement culture.

Skills

Root cause analysis

CAPA

NCRs handling

Audits

Analytical skills

Communication

Risk management

Cross-functional teamwork

Problem solving

Education

Bachelor's or Master's degree in Science, Manufacturing Engineering, Biomedical Engineering, Quality or a related discipline

Tools

Minitab

Q-Pulse

Job description

Quality Engineer (BBBH693246) Athlone, Republic of Ireland

Salary: EUR50000 - EUR55000 per annum

Location Athlone, Co. Westmeath
Salary: €50,000 per annum
Experience:3-4 years
About the Role
Our client, a leading organisation within the regulated manufacturing sector, is seeking a motivated and experienced Quality Engineer to join their team in Athlone.

Key Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with FDA requirements, ISO 13485 and applicable standards and regulations.
• Lead and support quality activities including root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate Non-Conformance Reports (NCRs), ensuring effective root cause analysis, corrective actions and timely closure.
• Support CAPA development, implementation and effectiveness monitoring.
• Support internal and external audits, including preparation, audit responses and follow-up actions.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues and drive continuous process improvement.
• Support product and process risk assessments, process validation, equipment qualification and other quality-related manufacturing activities.
• Review and maintain QMS documentation, including procedures, work instructions, inspection records and associated quality records.
• Support supplier quality activities, including supplier issues, corrective actions and quality performance monitoring.
• Support change control activities for product and process changes, ensuring quality requirements are addressed.
• Analyse quality data and trends to identify improvement opportunities and prevent recurring issues.
• Promote a strong quality and continuous improvement culture across the organisation.

Qualifications & Experience

• Bachelor's or Master's degree in Science, Manufacturing Engineering, Biomedical Engineering, Quality or a related discipline.
• 3-4 years' experience within Quality Engineering, Quality Assurance or a similar role in a regulated manufacturing environment.
• Previous experience within a regulated industry, preferably medical device manufacturing, is highly desirable.
• Practical experience with FDA Quality System requirements.
• Good understanding and practical application of ISO 13485.
• Experience with CAPA, NCRs, root cause analysis, change control, risk management and audits.
• Strong problem-solving and analytical skills, with the ability to investigate quality issues and implement effective corrective actions.
• Good understanding of manufacturing processes and quality control principles.
• Strong attention to detail with the ability to manage multiple quality activities effectively.
• Excellent communication and interpersonal skills with the ability to work effectively across cross-functional teams.

The following would be considered advantageous but are not essential:

• Knowledge or experience of EU MDR requirements.
• Knowledge of SPC, statistical analysis and quality improvement methodologies.
• Experience with process validation and equipment qualification.
• Exposure to supplier quality management.
• Experience working within cleanroom or controlled manufacturing environments.
• Lean Six Sigma or other recognised quality-related qualifications.
• Experience using quality and data analysis software such as Minitab, Q-Pulse or equivalent systems.

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